Trial Condition(s):

Endometriosis

Daily practice treatment and Influence of Visanne on the patient assessment of quality of life (DIVA)

Bayer Identifier:

16108

ClinicalTrials.gov Identifier:

NCT01595724

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.

Inclusion Criteria
- Female patients older than 18 years of age 
  - Clinical or laparoscopic diagnosis of endometriosis 
  - Having endometriosis related pain as leading symptom
  - Decision taken by physician to prescribe Visanne
  - Signed Informed Consent Form
Exclusion Criteria
- Contraindications listed in the local summary of product characteristics (SPC) have to be considered.

Trial Summary

Enrollment Goal
3006
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 
Locations

Investigative Site

Many Locations, Ukraine

Status
Completed
 
Locations

Investigative Site

Many Locations, Belarus

Status
Completed
 
Locations

Investigative Site

Many Locations, Kazakhstan

Status
Completed
 
Locations

Investigative Site

Many Locations, Egypt

Status
Completed
 
Locations

Investigative Site

Many Locations, Kuwait

Status
Completed
 
Locations

Investigative Site

Many Locations, Saudi Arabia

Status
Completed
 
Locations

Investigative Site

Many Locations, Jordan

Status
Completed
 
Locations

Investigative Site

Many Locations, Lebanon

Status
Completed
 
Locations

Investigative Site

Many Locations, Qatar

Status
Completed
 
Locations

Investigative Site

Many Locations, United Arab Emirates

Status
Completed
 

Trial Design